Abstract
A COMPARATIVE STUDY FOR PRE-FORMULATION AND STABILITY OF COMBINATION OF ATORVASTATINE AND EZETIMIBE

Tarek S. Makram*

ABSTRACT

Purpose: Study compatibility between ATV and EZT in suggested pre-formulation, the parameters of different SDF and effect of different manufacturing technique on the physical and chemical properties of the drug combination, then detection of expire date of the selected formula of drug combination prepared by different techniques. Methods: study interaction of drug combination by TLC, FTIR, DSC, and then study compatibility of drugs with excipients. The selected formula was evaluated in different dosage form by determine disintegration time, in vitro release studies, and dissolution profile. Finally, determination of expire date for the selected formula after storage for six month using HPLC procedure by applying of Arrhenius equation. Result: Solubility of two drugs in proved with increasing Ph above 5.5. There was probability of partial interaction between the two drugs. The selected formula (F5) was used as it increases release and solubility of the two drugs. The rate of release of two drugs in capsule was higher than tablet. Conclusion: Formula (F5) was preferred to use in drug combination. Capsules were recommended for drug combination then tablets. Shelf lives of drugs combination in capsules were being better then tablets. Storage for six month affect dissolution rate of drug combination.

Keywords: TLC, FTIR, DSC.


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